Fast-track Rehabilitation After Total Knee or Hip Arthroplasty

Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study

In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP.

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty; Hip Arthroplasty
• Intervention / Treatment: Other: fast-track rehabilitation; Other: standard care rehabilitation

• Study Type: Observational
• Enrollment (Actual): 58

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The recruitment will take place to Rehabilitation Unit of Don Gnocchi Foundation of Rovato (Brescia, Italy), from January 2016 to August 2016. An informed consent will be signed by each participant in agreement with Helsinki Declaration. The study is approved by the local Ethical Committee.

Description

Inclusion Criteria:

• adult people (>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb>9 g/l).

Exclusion Criteria:

• the presence of pain measured with NRS (NRS>4)
• rheumatoid arthritis, past surgery
• cancer
• neurological and psychiatric disorders
• dementia with Minimental Test<24
• pregnancy
• participation in the other clinical studies.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; fast-track rehabilitation	Other: fast-track rehabilitation
control group; standard care rehabilitation	Other: standard care rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Knee Society Score	Change from Baseline fast-track rehabilitation at 8th and 15th day
Merle D'Aubigne' scale	Change from Baseline fast-track rehabilitation at 8th and 15th day

Secondary Outcome Measures

Outcome Measure	Time Frame
Barthel Index	Change from Baseline fast-track rehabilitation at 8th and 15th day

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Chiara Arienti, PhD(s), IRCCS Don Gnocchi Foundation

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (ESTIMATE): January 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: fast-track rehabilitation; fast-track surgery
• Other Study ID Numbers: Fast Track Rehab